Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: KD026; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02434744

KD026-201

Details and patient eligibility

About

This study will compare the safety, tolerability and efficacy of the combination of KD026 and metformin compared to placebo and metformin on improving glycemic control in patients with type 2 diabetes mellitus.

Enrollment: 121 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes, with finger stick HbA1c ≥ 7.0% and ≤ 11.0% at screening visit, and HbA1c via venipuncture ≥ 7.0% and ≤ 11.0 % at the Qualification visit
• Have been on metformin for at least 12 weeks prior to screening visit and the metformin dose is not expected to change during the 4-week run-in period
• Have a BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2
• Men, post-menopausal women (defined as not having a menstrual period for at least 1 year), surgically sterile women (for at least 1 year), or women of childbearing potential with a negative pregnancy test within the last 24 hours
• Women of childbearing potential and men whose partners are of childbearing potential must agree to use two forms of accepted methods of contraception during the course of the study and for 1 month after their last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner

Exclusion criteria

• Have type 1 diabetes
• Taking antidiabetic medications other than or in addition to metformin
• Have fasting plasma glucose > 270 mg/dL at screening visit
• Have a serum creatinine ≥1.7 mg/dL or glomerular filtration rate <60 mL/min at screening visit
• Have a history of diabetic retinopathy
• Uncontrolled high blood pressure
• Have a history of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × the upper limit of normal (ULN) at screening visit.
• Have a history of a malignant cancer (other than basal cell, localized cervical, or squamous cell carcinoma of the skin that has been removed)
• Have a history or presence of gastrointestinal (GI) disease or major gastrointestinal surgery that, in the opinion of the investigator, could interfere with drug absorption
• Currently using any of prohibited medications that cannot be stopped
• Abuse alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units [1 unit is equivalent to a half pint of beer, 1 serving of hard liquor, or one glass of wine]
• History or presence of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria within the 2 years prior to screening visit
• Have a 12-lead ECG at screening visit that, in the opinion of the investigator, have abnormalities that may compromise safety in this study, including a QTc(F) interval (QT interval data corrected using Fridericia's formula) of > 450 msec
• Have a clinically significant abnormal laboratory result including thyroid-stimulating hormone (TSH) >1.5 × ULN at screening visit
• Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody/virus (HCV) or human immunodeficiency virus (HIV) antibodies at screening visit or a documented history of a positive result
• Pregnant or lactating woman
• Previously received KD026 (formerly named SLx-4090)
• Participated in a trial with any investigational drug within 4 weeks prior to screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 8 patient groups, including a placebo group

Cohort 1 100 mg KD026 BID

Experimental group

Description:

100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: KD026

Cohort 2 150 mg KD026 BID

Experimental group

Description:

150 mg KD026 BID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: KD026

Cohort 3 200 mg KD026 BID

Experimental group

Description:

200 mg KD026 BID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: KD026

Cohort 4 100 mg KD026 TID

Experimental group

Description:

100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: KD026

Cohort 1 Placebo

Placebo Comparator group

Description:

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: Placebo

Cohort 2 Placebo

Placebo Comparator group

Description:

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: Placebo

Cohort 3 Placebo

Placebo Comparator group

Description:

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: Placebo

Cohort 4 Placebo

Placebo Comparator group

Description:

Matched Placebo Dose TID in combination with Metformin for 12 weeks

Treatment:

Drug: Metformin

Drug: Placebo